Lupine, L. albus, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

No data about test item composition

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Lupine, L. albus, ext.

EC Number:

282-001-8

EC Name:

Lupine, L. albus, ext.

Cas Number:

84082-55-3

IUPAC Name:

Enzymatic hydrolysis products of Lupinus Albus, Fabaceae, seed

Test material form:

liquid

Details on test material:

Amber liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier (53940 Le genest St Isle FRANCE)
- Females nulliparous and non-pregnant
- Age at study initiation: about 7 weeks
- Weight at study initiation: 210.2g - 220.0g
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stain less steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (A04-10), ad libitum
- Water (e.g. ad libitum): Acidified, tap water (pH 2.5) (wtaer samples analyzed every 6 months for physico-chemical and bacteriological analysis)
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C ± 2° C,
- Humidity (%): from 50 ± 20%,
- Air changes (per hr): at least 10 cycles per hour
- Photoperiod : (12 hrs day / 12 hrs darkness).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

In the first step of the study, the test item was administrated by gavage under a volume of 2 mL/kg body weight (corresponding to 2000 mg/kg bw, according to study report).

Doses:

2 mL/ kg bw

No. of animals per sex per dose:

3 (females only)

Control animals:

no

Details on study design:

The animals were observed regularly on the day of administration (immediately, within 30 minutes after gavage, 1h, 2h, 3h and 4h after administration) and then at least once a day for at least 14 days.
Immediately after administration of the test item, attention was drawn to the signs of choking: in the event of death, the dead animals were immediately autopsied and it was verified that death was due to the toxicity of the test item and not to a track error.
The various parameters observed were: spontaneous activity, Preyer reflex, respiratory effect, convulsions, trembling, temperature, muscle tone, grip strength, palpebral ptosis, mydriasis, salivation, lacrimation, reversal reflex, piloerection, diarrhea, lethargy, Coma, changes in skin, coat, eyes, mucous membranes and mortality.

Animals were weighed on D-1 (day before the administration) and just before administering the test item, then on D4, D8 and D15 (equivalent to 3,7 an 14 days after the test item administration).

On D14, the animals were euthanized by intraperitoneal injection of sodium pentobarbital 6%, at a rate of 1.16 mL/ kg and bleeding at the femoral artery.
They were autopsied and the main organs were observed macroscopically.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

Slight piloerection was observed on treatment day.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not classifÌed based on a LD50 higher than 2000 mg/kg bw and no significant toxic effects observed at that dose level.

Executive summary:

The test item IN 04 was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423.

No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route in the rat.